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NOT YET RECRUITING
NCT07641998
PHASE1

Robot-Assisted Hematoma Evacuation With Intrahematoma Tenecteplase for Post-Reperfusion PH2 Hemorrhagic Transformation

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

The purpose of this phase I trial is to evaluate the safety and feasibility of robot-assisted stereotactic minimally invasive hematoma aspiration, followed when eligible by intrahematoma tenecteplase administration, in patients who develop symptomatic supratentorial PH2 hemorrhagic transformation after reperfusion therapy for acute ischemic stroke. The main study questions are whether this strategy is associated with an acceptable early rebleeding risk and whether it can achieve clinically meaningful hematoma reduction with accurate catheter placement and relief of hematoma-related mass effect.

Official title: A Phase I, Open-Label, Single-Arm Study of Robot-Assisted Stereotactic Minimally Invasive Hematoma Aspiration Followed by Intrahematoma Tenecteplase in Patients With Symptomatic Supratentorial PH2 Hemorrhagic Transformation After Reperfusion Therapy for Acute Ischemic Stroke

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-06-10

Completion Date

2026-12-30

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

DRUG

Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase

Procedure: Robot-assisted stereotactic minimally invasive hematoma aspiration and drainage. Using fused CT and/or MRI images, a robot-guided trajectory will be planned to avoid major vessels, eloquent cortex, and vulnerable peri-infarct tissue when feasible. Initial evacuation will be performed with passive drainage or very low-pressure aspiration, avoiding rapid decompression. Catheter position will be confirmed on postoperative CT. Drug: Tenecteplase (TNK) for intrahematoma administration. After a 2-hour postoperative stability CT confirms no rebleeding, the dose will be calculated as residual hematoma volume × 0.009 mg/mL, diluted to 1 mL with sterile water for injection, instilled through the indwelling catheter, and followed by a 3mL normal saline flush. The catheter will be clamped for 2 hours and then reopened for gravity drainage. TNK will be given once every 24 hours for up to 3 doses.

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China